Extended Self-Help for Smoking Cessation

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Forever Free Booklets

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01352195

MCC-15724

Details and patient eligibility

About

The primary purpose of this study is smoking cessation. The investigators are conducting a research study to learn how well the information from the program helps participants to quit smoking and remain smoke-free.

Full description

The investigators propose a randomized 3-arm design, with 660 smokers recruited into each condition. The three conditions will include: (1) Usual care (UC), which will comprise a single smoking cessation booklet developed by NCI; (2) Standard Repeated Mailings (Stand-RM), which will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies; and (3) Intensive Repeated Mailings (Inten-RM), which will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. Assessments will occur at six-month intervals, through 30 months. An overview of the design is depicted in Table 4, which will be referenced throughout the remainder of this proposal.

Enrollment: 2,124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Participants:

• Planned Participants: 1980 daily smokers (for a final sample of at least 1584 after attrition), recruited via multimedia advertisements (daily and weekly newspapers, radio, cable television, public transit ads, etc.), public service announcements, and direct community engagement.

Inclusion Criteria:

• smoking at least five cigarette per day over the past year
• not currently enrolled in a face-to-face smoking cessation program
• able to speak and read English
• desire to quit smoking, as indicated by a score of at least 5 ("Think I should quit, but not quite ready") on the Contemplation Ladder (Biener & Abrams, 1991)

Exclusion Criteria:

• number of participants from the same street address limited to 1
• no more than 2 referrals per participant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,124 participants in 3 patient groups

Usual Care (UC)

Active Comparator group

Description:

This condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003).

Treatment:

Behavioral: Forever Free Booklets

Standard Repeated Mailings (Stand-RM)

Active Comparator group

Description:

Stand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies.

Treatment:

Behavioral: Forever Free Booklets

Intensive Repeated Mailings (Inten-RM)

Active Comparator group

Description:

Inten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts.

Treatment:

Behavioral: Forever Free Booklets